The FDA requires that all SAEs that are unexpected and potentially related to the study medication must be reported to the FDA in writing within 15 calendar days. SAEs that are unexpected and related to study drug that meet the criteria for death or immediately life-threatening also require the study's medical monitor to notify the FDA by telephone, facsimile transmission or in writing as soon as possible but no later than 7 calendar days, with a follow-up written report within 15 calendar days. The study's medical monitor will prepare an expedited report for the FDA and copies will be distributed to all site investigators. Expedited reports will be placed in the Study Binder by the investigator upon receipt. The investigators will also forward a copy of all expedited reports to their local Investigational Review Boards in accordance with local guidelines.